Nataliya Y Kashirskaya1, Nikolay I Kapranov2, Suntje Sander-Struckmeier3, Vladimir Kovalev4. 1. Department of Cystic Fibrosis, Research Centre for Medical Genetics RAMS, Moskvorechye str. 1, Moscow 115478, Russia. Electronic address: kashirskayanj@mail.ru. 2. Department of Cystic Fibrosis, Research Centre for Medical Genetics RAMS, Moskvorechye str. 1, Moscow 115478, Russia. Electronic address: nikolay.i.kapranov@gmail.com. 3. Abbott Laboratories GmbH, Freundallee 9A, 30173 Hannover, Germany. Electronic address: suntje.sander@abbott.com. 4. Abbott Laboratories, Leningradskoye shosse 16A, Moscow 125171, Russia. Electronic address: vladimir.kovalev@abbott.com.
Abstract
BACKGROUND: Pancreatic enzyme replacement therapy is the foundation of nutritional management for exocrine pancreatic insufficiency (EPI). METHODS: A 3-month, open-label, multicentre study in Russia assessing safety, efficacy, and ease-of-use of Creon(®) Micro (5000 lipase units/spoon) in children aged 1 month to <4 years with EPI due to cystic fibrosis. Efficacy assessments included growth parameters. RESULTS: All 40 subjects (mean age 26.5 months) completed treatment. Adverse events occurred in 40% of the subjects (most commonly respiratory tract infection [15%], frequent bowel movements [8%], rhinitis, stomatitis, nasopharyngitis, and diarrhoea [all 5%]), none were serious or led to discontinuation. After 3 months, mean±SD increases from baseline z-scores were height/length-for-age 0.13±0.48, weight-for-age 0.20±0.39, and BMI-for-age 0.29±0.65. Treatment was rated 'easy' to administer by 95% caregivers and acceptance 'good'/'very good' by 90%. CONCLUSIONS: Creon Micro was well tolerated. Growth development parameters increased over the 3-month treatment period. Treatment was considered easy to use and acceptance was good.
BACKGROUND: Pancreatic enzyme replacement therapy is the foundation of nutritional management for exocrine pancreatic insufficiency (EPI). METHODS: A 3-month, open-label, multicentre study in Russia assessing safety, efficacy, and ease-of-use of Creon(®) Micro (5000 lipase units/spoon) in children aged 1 month to <4 years with EPI due to cystic fibrosis. Efficacy assessments included growth parameters. RESULTS: All 40 subjects (mean age 26.5 months) completed treatment. Adverse events occurred in 40% of the subjects (most commonly respiratory tract infection [15%], frequent bowel movements [8%], rhinitis, stomatitis, nasopharyngitis, and diarrhoea [all 5%]), none were serious or led to discontinuation. After 3 months, mean±SD increases from baseline z-scores were height/length-for-age 0.13±0.48, weight-for-age 0.20±0.39, and BMI-for-age 0.29±0.65. Treatment was rated 'easy' to administer by 95% caregivers and acceptance 'good'/'very good' by 90%. CONCLUSIONS: Creon Micro was well tolerated. Growth development parameters increased over the 3-month treatment period. Treatment was considered easy to use and acceptance was good.
Authors: Claude Lambré; José Manuel Barat Baviera; Claudia Bolognesi; Pier Sandro Cocconcelli; Riccardo Crebelli; David Michael Gott; Konrad Grob; Evgenia Lampi; Marcel Mengelers; Alicja Mortensen; Gilles Rivière; Inger-Lise Steffensen; Christina Tlustos; Henk Van Loveren; Laurence Vernis; Holger Zorn; Magdalena Andryszkiewicz; Yi Liu; Sandra Rainieri; Andrew Chesson Journal: EFSA J Date: 2022-01-12